The present invention relates to a layered drug delivery device in thin sheet form for oral/buccal transmucosal delivery of active drug to a human or animal.
The delivery of active substances into the blood stream poses a large challenge in the pharmaceutical sciences. Oral administration of pharmaceutical compositions has drawbacks including difficulty in keeping the active in a desired location for absorption, loss of drug due to decomposition in the acidic environment of the stomach, and reduced bioavailability due to metabolism of the active in the liver, poor solubility, and/or efflux.
There has been much interest in drug delivery through the oral mucosa. The buccal, gingival (e.g. gums, palate (e.g. roof of mouth), and sublingual (e.g. under-tongue) membranes offer several advantages for active delivery as compared to typical oral administration of the active. For example, actives administered through the oral mucosa have rapid onset of action, reach high concentration in the blood in short periods of time, avoid first-pass effect of hepatic metabolism, and avoid exposure of the drug to fluids of the gastrointestinal tract.
U.S. Pat. Nos. 4,517,173; 4,572,832; 4,713,243; 4,900,554 and 5,137,729 and Published US Patent Applications Nos. 2001/0051186 and 2004/0006111, all of which are incorporated herein for all purposes, describe delivering active substances through a mucosal membrane using thin film compositions. However, there is still a need for drug delivery device that allows for the delivery of unstable and/or hard to dissolve active ingredients through the mucosal membrane.